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New Combo Drug for Type 2 Diabetes Approved

Improvements of glycemic control were displayed in controlled studies of Jentadueto XR

The Food and Drug Administration (FDA) has approved Jentadueto XR (linagliptin, metformin HCl extended-release; Boehringer Ingelheim and Lilly) tablets as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both linagliptin and metformin are appropriate.

The safety and efficacy of Jentadueto XR were established in adequate and well-controlled studies of linagliptin and metformin co-administered in patients with type 2 diabetes who were inadequately controlled on diet and exercise and in combination with sulfonylurea.

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Jentadueto XR combines linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin, a biguanide. Linagliptin works by increasing hormones that stimulate the pancreas to produce more insulin and the liver to produce less glucose. Metformin works by decreasing glucose production in the liver and intestinal absorption.

Both Jentadueto (linagliptin, metformin HCl) and Jentadueto XR carry a boxed warning for the risk of lactic acidosis.

Jentadueto XR is available as 2.5mg/1000mg strength tablets in 60- and 180-count bottles, and 5mg/1000mg strength tablets in 30- and 90-count bottles. Jentadueto is already available as 2.5mg/500mg, 2.5mg/850mg, 2.5mg/1000mg strength tablets.